BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS LOI

    MDR report key: 6272731 · Received January 24, 2017

    Report

    Report Number
    6272731
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 9, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC. (AMO)
    Product Code
    OOE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOST SUCTION PRIOR TO DOCKING WITH THE LASER UNABLE TO MAINTAIN SUCTION AFTER APPLICATION TO THE EYE. A NEW LOI WAS OPENED TO COMPLETE THE PROCEDURE. PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR LOI-12, (BRAND NOT PROVIDED) (PER SITE REPORTER): REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57826 CATALYS LOI OPHTHALMIC FEMTOSECOND LASER OOE ABBOTT MEDICAL OPTICS, INC. (AMO) LOI-12 1216657

    Patients

    Seq Age Sex Outcome Treatment
    1